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510(k) Data Aggregation
K Number
K180720Device Name
Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel
Manufacturer
Date Cleared
2018-06-27
(100 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
Medibio Usa LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Medifine Pen Needle 3 Bevel and the Medifine Pen Needle Quinta 5 Bevel are indicated for use with a pen injector device for the subcutaneous injection of insulin.
Device Description
The Medifine Pen Needle consists of a needle with hub, and shield assembly. The needle shield is intended to provide physical protection to the needle with the hub. Blister paper covers the primary container maintains sterility of the needle covering the hub and the shield with the blister paper. The needle hub can be connected onto the pen injector device for the subcutaneous injection of insulin. The device offers two compatible types of needle (patient contact point) as below. The user can choose the needle as per their preference.
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